[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Rules and Regulations]
[Pages 4112-4121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-1785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N-0170]


Medical Device Reporting: Manufacturer Reporting, Importer 
Reporting, User Facility Reporting, Distributor Reporting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending its 
regulations governing reporting by manufacturers, importers, 
distributors and health care (user) facilities of adverse events 
related to medical devices. Amendments are being made to implement 
revisions to the Federal Food, Drug, and Cosmetic Act (the act) as 
amended by the Food and Drug Administration Modernization Act of 1997 
(FDAMA).

EFFECTIVE DATE:  March 27, 2000.

FOR FURTHER INFORMATION CONTACT:  Susan E. Bounds, Center for Devices 
and Radiological Health (HFZ-500), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.

SUPPLEMENTARY INFORMATION:

I. General

    In the Federal Register of September 14, 1984 (49 FR 36326), FDA 
issued medical device reporting regulations for manufacturers and 
importers under the act and the Medical Device Amendments of 1976 (the 
1976 amendments) (Public Law 94-295). To correct weaknesses noted in 
the 1976 amendments, and to better protect the public health by 
increasing reports of device-related adverse events, Congress enacted 
the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), 
which required medical device user facilities and distributors to 
report certain device-related adverse events.
    Distributor reporting requirements became effective on May 28, 
1992, following the November 26, 1991 (56 FR 60024), the publication of 
those provisions in a tentative final rule. In the Federal Register of 
September 1, 1993 (58 FR 46514), FDA published a notice announcing that 
the proposed distributor reporting regulations had become final by 
operation of law and were now codified in part 804 (21 CFR part 804).

[[Page 4113]]

    On June 16, 1992, the President signed into law the Medical Device 
Amendments of 1992 (the 1992 amendments) (Public Law 102-112) amending 
certain provisions of section 519 of the act (21 U.S.C. 360i) relating 
to reporting of adverse device events. Among other things, the 1992 
amendments amended section 519 of the act to modify the requirements 
for manufacturer and importer reporting. Under the regulations issued 
under the SMDA and the 1992 amendments, importers are required to 
report as manufacturers if they are engaged in manufacturing activities 
or to report as distributors if they are engaged solely in distribution 
activities.
    On November 21, 1997, the President signed FDAMA (Public Law 105-
115) into law. FDAMA made several changes regarding the reporting of 
adverse experiences related to devices. On May 12, 1998, FDA published 
a proposed rule (63 FR 26129) (hereinafter referred to as the May 1998 
proposal) and a direct final rule (63 FR 26069) (hereinafter referred 
to as the May 1998 direct final rule) to implement the amendments to 
the Medical Device Reporting (MDR) provisions. FDA received at least 
one significant adverse comment on the direct final rule. Accordingly, 
consistent with FDA's procedures on direct final rulemaking, FDA is 
withdrawing the May 1998 direct final rule and is addressing the 
comments in this final rule based upon the May 1998 proposal.
    The May 1998 proposal was intended to amend the medical device 
reporting requirements to implement the following changes made by 
FDAMA:
    1. Section 213(a) of FDAMA revised section 519(a) of the act to 
eliminate distributors as an entity required to report adverse device 
events. Importers are still required to report under section 519(a) of 
the act.
    2. Section 213(a) of FDAMA also amended section 519(a) of the act 
to clarify that existing requirements for distributors to keep records 
concerning adverse device events and make them available to FDA upon 
request continue to apply.
    3. Section 213(a)(2) of FDAMA revoked section 519(d) of the act, 
which required manufacturers, importers, and distributors to submit to 
FDA an annual certification concerning the number of reports filed 
under section 519(a) in the preceding year. As a result, certification 
requirements are eliminated.
    4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of 
the act to require that device user facilities submit an annual rather 
than a semiannual summary of their reports to FDA.
    5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of 
the act. This section had required FDA to disclose, upon request, the 
identity of a device user facility making a report under section 519(b) 
of the act if the identity of the device user facility was included in 
a report required to be submitted by a manufacturer, distributor, or 
importer. As a result of this change by FDAMA, FDA now may disclose the 
identity of a device user facility only: in connection with an action 
concerning a failure to report or false or fraudulent reporting; in a 
communication to the manufacturer of the device; or to the employees of 
the Department of Health and Human Services, the Department of Justice, 
and duly authorized committees and subcommittees of Congress.
    6. Section 422 of FDAMA states that FDA's regulatory authority 
under the act, relating to tobacco products, tobacco ingredients, and 
tobacco additives shall be exercised under the act as in effect on the 
day before the date of enactment of FDAMA. The proposal stated that, 
under this rule of construction, the reporting requirements for 
manufacturers and distributors (including distributors who are 
importers) of cigarettes or smokeless tobacco would remain unchanged.
    Furthermore, along with the substantive changes to the MDR 
provisions required by FDAMA, the agency proposed certain 
nonsubstantive changes to the organization of the provisions contained 
in parts 803 (21 CFR part 803) and 804. These organizational changes 
did not affect any reporting burdens; rather, the changes were made for 
the sake of clarity and consistency within the CFR.

II. Summary of Comments

    The agency received nine comments submitted by medical device 
manufacturers, importers, distributors, and trade associations.
    1. Four comments stated that the agency did not follow Congress' 
direction that FDA consider changing the distributor recordkeeping 
requirements. The Congressional Conference Committee (the Conference 
Committee) recommended that FDA consider limiting the length of time 
that distributors are required to retain records to a period of 6 years 
(the current requirement is a minimum of 2 years, or the expected life 
of the product). The Conference Committee also recommended that FDA 
consider providing for electronic retention of records.
    The agency disagrees that it did not properly follow Congress' 
direction or intent. The Conference Committee recommended that the 
agency consider changes to the distributor recordkeeping requirements. 
However, FDAMA contained no provisions that required any specific 
changes to the requirements.
    The agency carefully considered the recommendations of the 
conference committee. The agency determined that the protection of the 
public health would not be adequately served if distributor 
recordkeeping was limited to a period of 6 years. Under the new quality 
system regulations contained in part 820 (21 CFR part 820), 
manufacturers (including initial distributors of foreign manufacturers) 
must retain records for a period equal to the design and expected life 
of the device (but no less than 2 years). The agency believes it is 
appropriate to require distributors to retain records for the same time 
period. This is especially important because distributors are no longer 
required to report any adverse event information to the agency, and the 
agency's primary access to the distributor complaint information is 
through its periodic inspection and examination of the distributor 
records.
    FDA also considered electronic retention of distributor records. 
Prior to FDAMA and the proposed rule, the agency had not prohibited the 
electronic retention of records, nor did it intend to prohibit 
electronic recordkeeping based upon the proposal. When the distributor 
recordkeeping requirements were shifted from part 804 to part 803, the 
language remained largely unchanged. However, in order to avoid further 
confusion regarding electronic retention of records, the agency is 
modifying proposed Sec. 803.18(d)(1) to clarify that distributor 
records may be either written or electronic.
    2. Three comments stated that in describing distributor 
recordkeeping, reference to the quality system regulations, 
specifically Sec. 820.198 (Complaint files), is inappropriate because 
Sec. 820.198 applies only to manufacturers.
    The agency agrees with this comment in part. The section being 
revoked (804.35) references Sec. 820.198 because many of the 
recordkeeping requirements in Sec. 820.198 would apply to all 
distributors. However, for the sake of clarity, the agency is revising 
Sec. 803.18(d) to remove the reference to Sec. 820.198, and is 
substituting language to identify the relevant requirements from 
Sec. 820.198 that apply to distributors who are not importers.
    3. Two comments suggested that the requirement that importers 
submit

[[Page 4114]]

adverse event reports within 10 days be changed to allow 30 days for 
reporting.
    The agency agrees and is modifying the regulation accordingly. 
Prior to the SMDA, importers were subject to the same reporting 
timeframes as manufacturers under the 1984 MDR regulation. Consistent 
with the requirements of the SMDA, the 10-day reporting requirement was 
imposed on distributors and, because part 804 defined distributors to 
include importers, the 10-day reporting requirement was imposed on 
importers as well. Under FDAMA, distributors are no longer required to 
submit adverse event reports, but the reporting requirements continue 
to apply to importers. Because importers are subject to many of the 
same requirements as manufacturers under the new quality system 
regulations contained in part 820, the agency will allow importers the 
same 30 days it provides manufacturers to gather information and submit 
reports.
    4. One comment stated that the fields to be filled out on FDA Form 
3500A (MEDWATCH reporting form) should be specifically identified for 
importers. The comment also requested clarification regarding whether 
the agency's definition of ``importer'' for the purpose of MDR includes 
firms who sell directly to the ultimate user.
    The agency agrees that the fields to be filled out by importers on 
FDA Form 3500A should be specified within the regulation. Because the 
requirements and burdens would not be affected by revising the style 
and format of Sec. 803.43, the agency is modifying the section to be 
consistent with Secs. 803.32 and 803.52, which describe the information 
to be submitted on the MEDWATCH form. Furthermore, proposed Sec. 803.43 
was inadvertently misnumbered. For the sake of consistency in 
numbering, the final rule will renumber this section as Sec. 803.42.
    The agency notes that, because ``distributors'' had previously been 
defined to include ``importers,'' FDA Form 3500A does not specifically 
address importer information and does not use the term ``importers.'' 
However, block F of the MEDWATCH form is identified for use by device 
user facilities and distributors. An importer should continue to 
complete blocks A, B, D, E, and F until the form is revised to remove 
references to ``distributor'' and replace them with ``importer.''
    The agency clarifies that firms who purchase products from a 
foreign manufacturer and sell directly to the ultimate user are 
considered retailers and not importers under part 803 and are not 
required to report.
    5. One comment stated that distributor reporting is important for 
the protection of the public health. The comment recommended, as an 
alternative to distributor reporting, a modification to the medical 
device labeling requirements to require that manufacturer contact 
information be included in the labeling for all devices in order to 
ensure proper adverse event reporting.
    The agency agrees that consumers are likely to contact medical 
device distributors with their device complaints. Without distributor 
reporting, it is possible that the agency will not receive information 
regarding some complaints. However, under FDAMA, the agency no longer 
has the authority to require distributor reporting.
    Although distributors are no longer under an obligation to report 
adverse device events, the agency continues to encourage distributors 
to provide manufacturers with adverse event information so that 
consumer complaints may be appropriately investigated and reported.
    The alternative suggestion that manufacturer contact information be 
included in device labeling would be likely to increase the amount of 
information the manufacturer and the agency receives from the consumer. 
However, implementing this type of change to the medical device 
labeling regulation is beyond the scope of this rule. The agency is 
currently reviewing its medical device labeling regulation and 
considering certain modifications. The question of manufacturer contact 
information appearing on device labeling will be considered as part of 
that regulatory effort.
    6. One comment stated that the agency erroneously interpreted 
section 422 of FDAMA, regarding the regulation of tobacco products, 
tobacco ingredients, or tobacco additives. The comment stated that 
section 422 simply provides that nothing in FDAMA shall affect the 
question of whether or not FDA has authority to regulate such products. 
The comment suggests that, if FDA has the authority to regulate such 
products, they should be regulated in the same manner as other medical 
devices.
    The agency disagrees with this comment. Section 422 of FDAMA states 
that ``Nothing in this Act or the amendments made by this Act shall be 
construed to affect the question of whether the Secretary of Health and 
Human Services has any authority to regulate any tobacco product, 
tobacco ingredient, or tobacco additive.'' Although this language may 
suggest that FDAMA is simply silent regarding the agency's authority to 
regulate tobacco, section 422 goes on to state that ``Such authority, 
if any, shall be exercised under the Federal Food, Drug, and Cosmetic 
Act as in effect on the day before the date of the enactment of this 
act.'' Beyond the question of whether the agency has authority to 
regulate tobacco, this language directs the agency as to how it should 
exercise any such authority once pending litigation is resolved.
    Under section 422 of FDAMA, therefore, Congress neither affirms nor 
denies the agency's authority to regulate tobacco, but it does direct 
the agency to continue regulating tobacco as it had been doing prior to 
FDAMA (if authority to regulate tobacco exists). Prior to FDAMA, 
distributor reporting and manufacturer and distributor certification 
were required under the act. If the agency were to exercise its 
authority under the act ``as in effect on the day before the date of 
the enactment of [FDAMA],'' distributor reporting and manufacturer and 
distributor certification requirements would continue to apply to 
manufacturers and distributors of cigarettes and smokeless tobacco 
products.
    However, while the agency disagrees with the comment's 
interpretation of section 422 of FDAMA, FDA finds persuasive the 
comment's arguments that tobacco manufacturers and distributors should 
be exempt from the requirement of annual certification of MDR's and 
that distributors should be exempt from MDR reporting requirements 
under the residual authority of the act. The agency has authority under 
section 519(c) of the act to exempt, by regulation, any class of 
persons from the medical device reporting requirements upon a finding 
that such reporting by that class is not necessary to ``assure that a 
device is not adulterated or misbranded or * * * otherwise to assure 
its safety and effectiveness'' (21 U.S.C. 360i(c)). The agency finds 
that the statutory criteria for exemption are met because reasonable 
assurances will be provided by the remaining medical device reporting 
requirements, that is, reporting and recordkeeping required by 
manufacturers and importers and recordkeeping required by distributors.
    7. On its own initiative, FDA has revised Sec. 803.22(b)(2) to make 
clear that importers who receive reportable information about a device 
not imported by them need not submit a report to FDA but, instead, must 
forward the information to FDA along with a cover letter explaining 
that they do not import the device in question.

[[Page 4115]]

    8. On its own initiative, FDA has determined that it is not 
necessary for importers to submit supplemental reports under 
Sec. 803.56 as proposed. Instead, FDA will require importers to submit 
additional information only when requested by FDA under Sec. 803.15. No 
change to Sec. 803.15 is necessary.
    9. Also on its own initiative, FDA has made some nonsubstantive 
changes to the definitions in Sec. 803.3 in order to integrate the 
requirements for importer reporting into part 803.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The agency believes that this final rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. The Office of Management and Budget (OMB) has 
determined that this final rule is a significant regulatory action 
subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The rule codifies the elimination of reporting by 
distributors, continues reporting by importers as they have been doing 
to date with an extension of the time for reporting, increases 
protection from disclosure of the identity of device user facilities 
that have submitted reports, reduces summary reporting by device user 
facilities from semiannual to annual, eliminates annual certification 
for manufacturers and distributors (including importers) of medical 
devices, and makes other nonsubstantive changes. The agency certifies 
that this final rule will not have a significant negative economic 
impact on a substantial number of small entities. This final rule also 
does not trigger the requirement for a written statement under section 
202(a) of the Unfunded Mandates Reform Act because it does not impose a 
mandate that results in an expenditure of $100 million or more by 
State, local, or tribal governments in the aggregate, or by the private 
sector, in any one year.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are shown below with an estimate of the annual reporting 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Reporting and recordkeeping requirements for manufacturers, 
importers, user facilities, and distributors of medical devices under 
the FDA Modernization Act (FDAMA)--General Requirements.
    Description: FDAMA contained provisions that affect medical device 
reporting in a variety of ways. Section 213 of FDAMA eliminated the 
reporting requirements for medical device distributors (but not for 
importers), as well as the certification requirements for medical 
device manufacturers and distributors. This section of FDAMA also 
modified the summary reporting requirements for user facilities to 
require annual, rather than semiannual, reporting, and increased 
confidentiality of user facility identities.
    This final rule amends FDA's regulations in part 803 and revokes 
part 804 to reflect the changes to medical device reporting made by 
FDAMA. The final rule has also been amended to implement the exemptions 
for manufacturers and distributors of cigarettes and smokeless tobacco 
products discussed below.
    In accordance with 5 CFR 1320.8(d), on May 12, 1998, requests for 
public comment were published in the Federal Register (see 63 FR 26069 
and 63 FR 26129). Several comments were received in response to the 
proposed rule and are discussed in detail previously in this final 
rule.
    Four comments objected that FDA did not follow the congressional 
recommendation in the conference report on FDAMA that FDA limit the 
time that distributors be required to keep records to a maximum of 6 
years. The direct final rule required that distributors keep records 
for 2 years or the expected life of the device, whichever is greater.
    FDA carefully considered the recommendations of the conference 
committee. The agency determined that the protection of the public 
health would not be adequately served if distributor recordkeeping was 
limited to a period of 6 years. Under the new quality system 
regulations contained in part 820, manufacturers (including initial 
distributors of foreign manufacturers) must retain records for a period 
equal to the design and expected life of the device (but no less than 2 
years). The agency believes it is appropriate to require distributors 
to retain records for the same time period. This is especially 
important because distributors are no longer required to report any 
adverse event information to the agency, and the agency's primary 
access to the distributor complaint information is its periodic 
inspection and examination of the distributor records.
    FDA considered electronic retention of distributor records. Prior 
to FDAMA and the May 1998 proposal, the agency had not prohibited the 
electronic retention of records, nor did it intend to prohibit 
electronic recordkeeping based upon the May 1998 proposal. When the 
distributor recordkeeping requirements were shifted from part 804 to 
part 803, the language remained largely unchanged. However, in order to 
avoid further confusion regarding electronic retention of records, the 
agency is modifying proposed Sec. 803.18(d)(1) to clarify that 
distributor records may be either written or electronic.
    Three comments stated that it is inappropriate to refer to the 
quality systems regulations (Sec. 820.198) in describing distributor 
recordkeeping because Sec. 820.198 does not apply to distributors.
    FDA agrees and has revised Sec. 803.18(d) accordingly to remove the 
reference to Sec. 820.198. FDA is substituting language to identify the 
relevant requirements from Sec. 820.198 that apply to distributors who 
are not importers. FDA notes, however, that Sec. 820.198 does apply to 
importers of devices.
    Two comments suggested that the reporting timeframe for importers 
should be changed to 30 days from 10 days.
    FDA agrees with these comments and has revised the final rule. 
Previously,

[[Page 4116]]

importers were included in part 804 with the reporting requirements for 
distributors. Because distributors are no longer required to report, 
part 804 is eliminated and importers are included in part 803 with 
manufacturers. The 30-day timeframe is consistent with the timeframe 
for manufacturers.
    One comment suggested that the form for reporting adverse events 
(FDA Form 3500A) should be revised to refer specifically to importers. 
Another comment asked for clarification as to whether a person who 
sells directly to the ultimate user may be considered an ``importer''.
    The agency agrees that the fields to be filled out by importers on 
FDA Form 3500A should be specified within the regulation. Because the 
requirements and burdens would not be affected by revising the style 
and format of Sec. 803.43, the agency is modifying the section to be 
consistent with Secs. 803.32 and 803.52, which describe the information 
to be submitted on the MEDWATCH form. Furthermore, proposed Sec. 803.43 
was inadvertently misnumbered. For the sake of consistancy in 
numbering, the final rule will renumber this section as Sec. 803.42.
    The agency notes that, because ``distributors'' had previously been 
defined to include ``importers,'' FDA Form 3500A does not specifically 
address importer information and does not use the term, ``importers.'' 
However, block F of the MEDWATCH form is identified for use by device 
user facilities and distributors. An importer should continue to 
complete blocks A, B, D, E, and F until the form is revised to remove 
references to ``distributor'' and replace them with ``importer.'' The 
agency clarifies that firms who purchase products from a foreign 
manufacturer and sell directly to the ultimate user are considered 
retailers and not importers under part 803 and are not required to 
report.
    One comment suggested that distributor reporting is important for 
the protection of the public health and recommended that, as an 
alternative to distributor reporting, FDA should require manufacturer 
contact information on the labeling to assure proper adverse event 
reporting.
    The agency agrees that consumers are likely to contact medical 
device distributors with their device complaints. Without distributor 
reporting, it is possible that the agency will not receive information 
regarding some complaints. However, under FDAMA, the agency no longer 
has the authority to require distributor reporting. Although FDA cannot 
require distributor reporting, FDA encourages distributors to report 
adverse event information to manufacturers so that they may investigate 
and report it as appropriate. The suggestion that FDA require 
manufacturer contact information on the labeling is beyond the scope of 
this rule and FDA will consider it separately.
    One comment objected that FDA incorrectly interpreted section 422 
of FDAMA regarding the regulation of tobacco products, tobacco 
ingredients and tobacco additives. The comment stated that section 422 
only means that nothing in FDAMA shall affect whether FDA has the 
authority to regulate tobacco products. The comment further said that 
section 422 of FDAMA does not mean, as FDA believes, that the 
requirements, such as MDR reporting, for manufacturers and distributors 
of tobacco products are unchanged by FDAMA.
    The agency disagrees with this comment. Section 422 of FDAMA states 
that ``Nothing in this Act or the amendments made by this Act shall be 
construed to affect the question of whether the Secretary of Health and 
Human Services has any authority to regulate any tobacco product, 
tobacco ingredient, or tobacco additive.'' Although this language may 
suggest that FDAMA is simply silent regarding the agency's authority to 
regulate tobacco, section 422 of FDAMA goes on to state that ``Such 
authority, if any, shall be exercised under the Federal Food, Drug, and 
Cosmetic Act as in effect on the day before the date of the enactment 
of this act.'' Beyond the question of whether the agency has authority 
to regulate tobacco, this language directs the agency as to how it 
should exercise such authority once pending litigation is resolved.
    Under section 422 of FDAMA, therefore, Congress neither affirms nor 
denies the agency's authority to regulate tobacco, but it does direct 
the agency to continue regulating tobacco as it had been doing prior to 
FDAMA (if authority to regulate tobacco exists). Prior to FDAMA, 
distributor reporting and manufacturer and distributor certification 
were required under the act. If the agency were to exercise its 
authority under the act ``as in effect on the day before the date of 
the enactment of [FDAMA],'' distributor reporting and manufacturer and 
distributor certification requirements would continue to apply to 
manufacturers and distributors of cigarettes and smokeless tobacco 
products.
    However, while the agency disagrees with the comment's 
interpretation of section 422 of FDAMA, FDA finds persuasive the 
comment's arguments that tobacco manufacturers should be exempt from 
the requirement of annual certification of MDR's and that distributors 
should be exempt from MDR reporting requirements under the residual 
authority of the act. The agency has authority under section 519(c) of 
the act to exempt, by regulation, any person from the medical device 
reporting requirements upon a finding that such reporting is not 
necessary to ``assure that a device is not adulterated or misbranded or 
* * * otherwise to assure its safety and effectiveness'' (21 U.S.C. 
360i(c)). The agency finds that the statutory criteria for exemption 
are met in light of the fact that Congress has repealed the 
requirements for manufacturer and distributor annual certification and 
distributor reporting. A reasonable assurance of the safety and 
effectiveness of tobacco products will be provided by the remaining 
medical device reporting requirements, that is, reporting and 
recordkeeping required of manufacturers and importers and recordkeeping 
required of distributors.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 4117]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
     21 CFR Section/FDA Form          No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
803.15                                 50               1              50               4             200
803.19                                150               1             150               3             450
803.22(b)(2)                          100               1             100                .25           25
803.33 (FDA Form 3419)              1,800               1           1,800               1           1,800
803.40                                195               1             195               3             585
803.55 (FDA Form 3417)              1,000              20          20,000               1.1        22,000
Total                                                                                             25,060
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records      recordkeeper
----------------------------------------------------------------------------------------------------------------
803.17                              2,000               1           2,000               3.3         6,600
803.18                             39,764               1          39,764               1.5        59,646
Total                                                                                             66,246
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burdens under this direct final rule are explained as follows:

A. Reporting Requirements

    Prior to the program change reflected in this rule, distributors 
(including importers) were required to submit supplemental information 
under Sec. 804.32. Distributors (who are not importers) are no longer 
required to submit MDR reports (including supplemental reports), and 
FDA has determined that it will not be necessary for importers to 
submit supplemental information except when FDA requests additional 
information under Sec. 803.15. FDA has revised the final rule 
accordingly. Section 803.15 provides that FDA may request a reporter to 
submit additional or clarifying information concerning an MDR report 
when FDA determines that additional information is necessary for the 
protection of the public health. The burden estimate for this section 
includes only the burden for importers.
    Prior to the program change reflected in this rule, Sec. 803.19 
allowed manufacturers or user facilities to request an exemption or 
variance from the reporting requirements. The agency had estimated that 
it would receive approximately 100 such requests annually. Distributors 
(including importers) were able to request an exemption or variance 
from the reporting requirements under Sec. 804.33. Under this rule, 
Sec. 803.19 is modified to transfer the exemption provisions for 
importers of medical devices from Sec. 804.33 to Sec. 803.19. 
Furthermore, distributors (who are not importers) of medical devices 
are no longer required to submit MDR reports under this rule. The 
estimated burden for Sec. 803.19 is further adjusted to reflect the 
agency's actual experience with this type of submission.
    Prior to the program change reflected in this rule, 
Sec. 803.22(b)(2) provided that, if a manufacturer erroneously receives 
information about an adverse event concerning a device that they had 
not manufactured, the manufacturer must submit the report to FDA along 
with a cover letter explaining that the device in question was not 
manufactured by that firm. This final rule amends Sec. 803.22(b)(2) to 
apply the same requirement to importers. The requirements of 
Sec. 803.22(b)(2) were not previously reviewed by OMB under the PRA. 
Thus, the estimated burden reflects FDA's experience with this 
provision with regard to manufacturers and includes the estimated 
burden for both manufacturers and importers.
    Prior to the program change reflected in this rule, Sec. 803.33 
required medical device user facilities to submit summary reports 
semiannually. Under this rule, user facilities are required to submit 
summary reports annually, thereby significantly decreasing the 
reporting burden on user facilities. The estimated burden for this 
section is also adjusted to reflect the agency's actual experience with 
this type of submission. FDA Form 3419 is being revised to reflect this 
change.
    Under this rule the reporting requirement for importers of medical 
devices previously codified under Sec. 804.25 is being transferred to 
Sec. 803.40. The estimated burden for importer reporting is based upon 
the agency's actual experience with this type of submission. Section 
803.40 requires importers to submit reports within 30 days after 
learning of the reportable event rather than 10 days as provided in 
Sec. 804.25; this change does not affect the burden.
    This rule does not amend Sec. 803.55 but FDA is seeking approval 
for FDA Form 3417 on which baseline reports are to be submitted. The 
agency's estimate is based on FDA's actual experience with this type of 
submission.
    Prior to the program change reflected in this rule, Sec. 803.57 
required medical device manufacturers to annually certify as to the 
number of reports submitted during the previous year, or that no such 
reports had been submitted. Distributors (including importers) were 
required to certify under Sec. 804.30. As stated above, FDA is also 
exempting manufacturers and distributors of cigarettes and smokeless 
tobacco products from the requirement of annual certification. 
Therefore, under this rule, Secs. 803.57 and 804.30 are being 
eliminated.
    Because distributors, including distributors of cigarettes and 
smokeless tobacco products, will no longer be required to report, the 
final rule also removes Secs. 804.25 (Reports by distributors), 804.32 
(Supplemental information), and 804.33 (Alternative reporting 
requirements).

B. Recordkeeping Requirements

    Prior to the program change reflected in this rule, Sec. 803.17 
required manufacturers and user facilities to establish written 
procedures for employee education, complaint

[[Page 4118]]

processing, and documentation of information related to MDR's. Under 
this rule, the requirements for establishing written MDR procedures for 
importers of medical devices have been transferred to Sec. 803.17. The 
agency believes that the majority of manufacturers, user facilities, 
and importers have already established written procedures to document 
complaints and information related to MDR reporting as part of their 
internal quality control system. The agency has estimated that no more 
than 2,000 such entities would be required to establish new procedures, 
or revise existing procedures, in order to comply with this provision. 
For those entities, a one-time burden of 10 hours, annualized over a 
period of 5 years, is estimated for establishing written MDR 
procedures. The remainder of manufacturers, user facilities, and 
importers not required to revise their written procedures to comply 
with this provision are excluded from the burden because the 
recordkeeping activities needed to comply with this provision are 
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
    Prior to the program change reflected in this rule, Sec. 803.18 
required manufacturers and user facilities to establish and maintain 
MDR event files. Distributors (including importers) were required to 
establish and maintain MDR event files under Sec. 804.35. Under this 
rule, Sec. 803.18 is modified to transfer the recordkeeping 
requirements for importers and other distributors of medical devices 
including cigarettes and smokeless tobacco products from Sec. 804.35 
and Sec. 804.35 is removed. As discussed above, this recordkeeping may 
be done in an electronic format.
    Under the proposed rule, distributors of cigarettes and smokeless 
tobacco products would have been required to establish written internal 
procedures for evaluating and reporting events. Because distributors of 
cigarettes and smokeless tobacco products will not be required to 
report under the final rule, Sec. 804.34 is deleted from the final 
rule.
    The information collections of this final rule have been submitted 
to OMB for review. Prior to the effective date of the final rule, FDA 
will publish a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove the information collection provisions 
of this final rule. An agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

List of Subjects in 21 CFR Parts 803 and 804

    Imports, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
chapter I is amended as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for 21 CFR part 803 continues to read as 
follows:

    Authority:  21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    2. Section 803.1 is amended by revising paragraph (a) to read as 
follows:


Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device 
reporting. Under this part, device user facilities, importers, and 
manufacturers, as defined in Sec. 803.3, must report deaths and serious 
injuries to which a device has or may have caused or contributed, must 
establish and maintain adverse event files, and must submit to FDA 
specified followup and summary reports. Medical device distributors, as 
defined in Sec. 803.3, are also required to maintain records of 
incidents (files). Furthermore, manufacturers and importers are also 
required to report certain device malfunctions. These reports will 
assist FDA in protecting the public health by helping to ensure that 
devices are not adulterated or misbranded and are safe and effective 
for their intended use.
* * * * *
    3. Section 803.3 is amended by redesignating paragraphs (m) through 
(ee) as paragraphs (n) through (ff), respectively; by revising 
paragraph (c), the first sentence of paragraph (f), newly redesignated 
paragraphs (p) introductory text and (p)(1), paragraph (r) introductory 
text and paragraph (r)(2), and by adding paragraphs (g) and (m) to read 
as follows:


Sec. 803.3  Definitions.

* * * * *
    (c) Become aware means that an employee of the entity required to 
report has acquired information reasonably suggesting a reportable 
adverse event has occurred.
    (1) Device user facilities are considered to have ``become aware'' 
when medical personnel, as defined in paragraph (s) of this section, 
who are employed by or otherwise formally affiliated with the facility, 
acquire such information about a reportable event.
    (2) Manufacturers are considered to have become aware of an event 
when:
    (i) Any employee becomes aware of a reportable event that is 
required to be reported within 30 days or that is required to be 
reported within 5 days under a written request from FDA under 
Sec. 803.53(b); and
    (ii) Any employee, who is a person with management or supervisory 
responsibilities over persons with regulatory, scientific, or technical 
responsibilities, or a person whose duties relate to the collection and 
reporting of adverse events, becomes aware that a reportable MDR event 
or events, from any information, including any trend analysis, 
necessitate remedial action to prevent an unreasonable risk of 
substantial harm to the public health.
    (3) Importers are considered to have become aware of an event when 
any employee becomes aware of a reportable event that is required to be 
reported by an importer within 30 days.
* * * * *
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in paragraphs (l), (b), (t), (u), and 
(v), respectively, of this section, which is not a ``physician's 
office,'' as defined in paragraph (w) of this section. * * *
    (g) Distributor means, for the purposes of this part, any person 
(other than the manufacturer or importer) who furthers the marketing of 
a device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate user, but who does not repackage 
or otherwise change the container, wrapper or labeling of the device or 
device package. One who repackages or otherwise changes the container, 
wrapper, or labeling, is a manufacturer under paragraph (o) of this 
section.
* * * * *
    (m) Importer means, for the purposes of this part, any person who 
imports a device into the United States and who furthers the marketing 
of a device from the original place of manufacture to the person who 
makes final delivery or sale to the ultimate user, but who does not 
repackage or otherwise change the container, wrapper, or labeling of 
the device or device package. One who repackages or otherwise changes 
the container, wrapper, or labeling, is a manufacturer under paragraph 
(o) of this section.
* * * * *
    (p) Manufacturer or importer report number means the number that 
uniquely identifies each individual adverse event report submitted by a

[[Page 4119]]

manufacturer or importer. This number consists of three parts as 
follows:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. (If the 
manufacturing site or the importer does not have a registration number, 
FDA will assign a temporary MDR reporting number until the site is 
officially registered. The manufacturer or importer will be informed of 
the temporary number.);
* * * * *
    (r) MDR reportable event (or reportable event) means:
    (1) * * *
    (2) An event about which manufacturers or importers have received 
or become aware of information that reasonably suggests that one of 
their marketed devices:
    (i) May have caused or contributed to a death or serious injury; or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause a 
death or serious injury if the malfunction were to recur.
* * * * *


Sec. 803.9  [Amended]

    4. Section 803.9 Public availability of reports is amended by 
adding ``or'' after the semicolon at the end of paragraph (c)(2), by 
removing paragraph (c)(3), and by redesignating paragraph (c)(4) as 
paragraph (c)(3).
    5. Section 803.10 is amended by revising the heading and paragraph 
(a)(2), and by adding paragraph (b) to read as follows:


Sec. 803.10  General description of reports required from user 
facilities, importers, and manufacturers.

    (a) * * *
    (2) User facilities must submit annual reports as described in 
Sec. 803.33.
    (b) Importers must submit MDR reports of individual adverse events 
within 30 days after the importer becomes aware of an MDR reportable 
event as described in Sec. 803.3. Importers must submit reports of 
device-related deaths or serious injuries to FDA and to the 
manufacturer and reports of malfunctions to the manufacturer.
* * * * *


Sec. 803.11  [Amended]

    6. Section 803.11 Obtaining the forms is amended in the first 
sentence by adding the word ``, importers,'' after the phrase ``User 
facilities''.
    7. Section 803.12 is amended by revising paragraph (b) to read as 
follows:


Sec. 803.12  Where to submit reports.

* * * * *
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
* * * * *


Sec. 803.17  [Amended]

    8. Section 803.17 Written MDR procedures is amended in the 
introductory text by adding the word ``, importers,'' after the phrase 
``User facilities''.
    9. Section 803.18 is amended by revising the heading, the first 
sentence of paragraphs (a) and (b)(1) introductory text, paragraphs 
(b)(1)(ii) and (b)(2), and the second sentence of paragraph (c), and by 
adding paragraph (d) to read as follows:


Sec. 803.18  Files and distributor records.

    (a) User facilities, importers, and manufacturers shall establish 
and maintain MDR event files. *  *  *
    (b)(1) For purposes of this part, ``MDR event files'' are written 
or electronic files maintained by user facilities, importers, and 
manufacturers. * * *
* * * * *
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., an importer, distributor, or manufacturer).
    (2) User facilities, importers, and manufacturers shall permit any 
authorized FDA employee during all reasonable times to access, to copy, 
and to verify the records required by this part.
    (c) * * * Manufacturers and importers shall retain an MDR event 
file relating to an adverse event for a period of 2 years from the date 
of the event or a period of time equivalent to the expected life of the 
device, whichever is greater. * * *
    (d)(1) A device distributor shall establish and maintain device 
complaint records containing any incident information, including any 
written, electronic, or oral communication, either received by or 
generated by the firm, that alleges deficiencies related to the 
identity (e.g., labeling), quality, durability, reliability, safety, 
effectiveness, or performance of a device. Information regarding the 
evaluation of the allegations, if any, shall also be maintained in the 
incident record. Device incident records shall be prominently 
identified as such and shall be filed by device, and may be maintained 
in written or electronic form. Files maintained in electronic form must 
be backed up.
    (2) A device distributor shall retain copies of the records 
required to be maintained under this section for a period of 2 years 
from the date of inclusion of the record in the file or for a period of 
time equivalent to the expected life of the device, whichever is 
greater, even if the distributor has ceased to distribute the device 
that is the subject of the record.
    (3) A device distributor shall maintain the device complaint files 
established under this section at the distributor's principal business 
establishment. A distributor that is also a manufacturer may maintain 
the file at the same location as the manufacturer maintains its 
complaint file under Secs. 820.180 and 820.198 of this chapter. A 
device distributor shall permit any authorized FDA employee, during all 
reasonable times, to have access to, and to copy and verify, the 
records required by this part.
* * * * *


Sec. 803.19  [Amended]

    10. Section 803.19 Exemptions, variances, and alternative reporting 
requirements is amended by adding in paragraphs (b) and (c) the word 
``, importers,'' before the phrase ``or user facility'', and by adding 
in paragraph (c) a comma after the word ``variance''.
    11. Section 803.20 is amended by revising the last sentence of the 
introductory text of paragraph (a), paragraph (a)(1), and the first 
sentence of paragraph (a)(2), and by adding paragraph (b)(2) to read as 
follows:


Sec. 803.20  How to report.

    (a) * * * The form has sections that must be completed by all 
reporters and other sections that must be completed only by the user 
facility, importer, or manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device, and the ``initial reporter'' (i.e., the 
first person or entity that submitted the information to the user 
facility, manufacturer, or importer).
    (2) The back part of the form contains sections to be completed by 
user facilities, importers, and manufacturers. * * *
    (b) * * *
    (2) Importers are required to submit death and serious injury 
reports to FDA and the device manufacturer and submit malfunction 
reports to the manufacturer only:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury.

[[Page 4120]]

    (ii) Within 30 days of receiving information that a device marketed 
by the importer has malfunctioned and that such a device or a similar 
device marketed by the importer would be likely to cause or contribute 
to a death or serious injury if the malfunction were to recur.
* * * * *


Sec. 803.22  [Amended]

    12. Section 803.22 When not to file is amended by adding in 
paragraphs (a) and (b)(1) the word ``, importer,'' after the word 
``facility'' and in paragraph (b)(2) by adding the phrase ``or 
importer'' after the word ``manufacturer'' each time it appears and by 
adding the phrase ``or imported'' after the word ``manufactured'' each 
time it appears.


Sec. 803.33  [Amended]

    13. Section 803.33 Semiannual reports is amended by revising the 
heading to read ``Annual reports''; in the introductory text of 
paragraph (a) by removing the phrase ``(for reports made July through 
December) and by July 1 (for reports made January through June)''; in 
the introductory text of paragraph (a) and paragraphs (a)(5), (a)(7) 
introductory text, and (c) by removing the word ``semiannual'' wherever 
it appears and adding in its place the word ``annual''; in paragraph 
(a)(1) by revising the reference ``Sec. 803.3(dd)'' to 
``Sec. 803.3(ee)''; in paragraph (a)(2) by removing the phrase ``and 
period, e.g., January through June or July through December'' and in 
paragraph (a)(7)(vi) by adding the word ``importer,'' after the word 
``distributor,''.
    14. Subpart D, consisting of Secs. 803.40 and 803.42, is added to 
read as follows:

Subpart D--Importer Reporting Requirements

Sec.
803.40  Individual adverse event reporting requirements; importers.
803.42  Individual adverse event report data elements.


Sec. 803.40  Individual adverse event reporting requirements; 
importers.

    (a) An importer shall submit to FDA a report, and a copy of such 
report to the manufacturer, containing the information required by 
Sec. 803.42 on FDA form 3500A as soon as practicable, but not later 
than 30 days after the importer receives or otherwise becomes aware of 
information from any source, including user facilities, individuals, or 
medical or scientific literature, whether published or unpublished, 
that reasonably suggests that one of its marketed devices may have 
caused or contributed to a death or serious injury.
    (b) An importer shall submit to the manufacturer a report 
containing information required by Sec. 803.42 on FDA form 3500A, as 
soon as practicable, but not later than 30 days after the importer 
receives or otherwise becomes aware of information from any source, 
including user facilities, individuals, or through the importer's own 
research, testing, evaluation, servicing, or maintenance of one of its 
devices, that one of the devices marketed by the importer has 
malfunctioned and that such device or a similar device marketed by the 
importer would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur.


Sec. 803.42  Individual adverse event report data elements.

    Individual medical device importer reports shall contain the 
following information, in so far as the information is known or should 
be known to the importer, as described in Sec. 803.40, which 
corresponds to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, that is:
    (i) Death;
    (ii) Life threatening injury or illness;
    (iii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iv) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including preexisting medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
FDA, if known.
    (e) Importer information (Block F) shall contain the following:
    (1) Whether reporter is an importer;
    (2) Importer report number;
    (3) Importer address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the importer became aware of the event (month, day, year);
    (7) Type of report (initial or followup (if followup, include 
report number of initial report));
    (8) Date of the importer report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
FDA ``Coding Manual For Form 3500A'');
    (11) Whether a report was sent to FDA and the date it was sent 
(month, day, year);
    (12) Location, where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address; if available.


Sec. 803.57  [Removed]

    15. Section 803.57 Annual certification is removed.

PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING

    16. Part 804 is removed.


[[Page 4121]]


    Dated: August 6, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-1785 Filed 1-25-00; 8:45 am]
BILLING CODE 4160-01-F